Each material 8-K filed by a company listed on a US stock exchange (NYSE, Nasdaq, Cboe), read and summarized: what happened, the key numbers, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). This page lists the last 45 days; every brief stays on its company's 8-K page (1675 companies, A–Z).
BioCardia said it finished its clinical consultation with Japan's PMDA on application materials for the CardiAMP Cell Therapy System for ischemic heart failure, a step toward submitting a marketing approval application. The company states that completing consultations does not constitute regulatory approval, and the product remains subject to PMDA review.
Consultation with Japan's PMDA on application materials completed, announced November 6, 2026
CardiAMP is intended for ischemic heart failure; CEO Peter Altman targets first patient treatments in Japan and commercial revenues in 2028
Completion does not equal regulatory approval; product remains subject to PMDA review
Supernus said the FDA recognized seven years of orphan-drug exclusive approval for ONAPGO (apomorphine HCl) for motor fluctuations in adults with advanced Parkinson's disease, with the exclusivity period starting on the February 3, 2025 approval date. The company also submitted a supplemental New Drug Application for a second supplier of ONAPGO and continues to expect potential FDA approval of that supplier by mid-year 2027. The filing gives no financial figures, but the exclusivity period is a regulatory protection for the product.
FDA recognized seven years of orphan-drug exclusive approval for ONAPGO, with the period starting February 3, 2025.
ONAPGO is described as the first and only subcutaneous apomorphine infusion device for motor fluctuations in adults with advanced Parkinson's disease.
Supernus submitted an sNDA for a second supplier of ONAPGO and expects potential FDA approval by mid-year 2027.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.
Frequently asked questions
Which filings get a brief?
Form 8-K filings by companies listed on a US stock exchange (NYSE, Nasdaq, Cboe; not over-the-counter stocks) that report a material event: results (Item 2.02), deals (1.01, 2.01), executive changes (5.02), restructuring (2.05), impairments (2.06), delisting notices (3.01), restatements (4.02), cybersecurity incidents (1.05), bankruptcy (1.03) and Regulation FD or other events (7.01, 8.01). Routine filings such as vote results or exhibits only are skipped.
How is the impact score set?
The AI rates each filing from 1 (routine) to 5 (major, such as a merger, bankruptcy or restatement) based only on what the filing says. It is a reading aid for sorting the day's filings, not a prediction of how the stock will move.
How quickly do briefs appear?
On weekdays the SEC filing feed is checked every 5 minutes from 6 am to 5:45 pm Eastern, when nearly all 8-Ks come in, and every hour after that until 10 pm. Briefs of the 1,000 largest companies follow within minutes; the others usually within the hour, or later the same day when many filings arrive at once.
Which companies are covered?
Every company with shares listed on the NYSE, Nasdaq or Cboe that files 8-Ks, about 4,500 of them. Foreign companies that report on Form 6-K instead are not included. The S&P 1500 only filter above narrows the list to the large, mid and small caps of the S&P Composite 1500.
Are older briefs kept?
Yes. This page shows the last 45 days, but every brief ever published stays online: each has its own page, and each company has an 8-K page listing all of its briefs, newest first, linked from its stock page and from the A-Z list of companies.